Cooling cap helps cancer patients preserve their hair during chemotherapy, clinical trial shows

A woman wears a cooling cap. A new study has found strong evidence that the caps prevent hair loss during chemotherapy treatment.
(Baylor College of Medicine)

It’s been one year since the Food and Drug Administration approved the first cooling cap system to help cancer patients in the U.S. preserve their hair during chemotherapy treatments. A new clinical trial strengthens the case that cooling caps really do reduce the risk of hair loss.

Among 95 breast cancer patients who were randomly assigned to test a cooling cap, 48 — or 51% — still had a good amount of hair after four cycles of chemotherapy. Meanwhile, among 47 control patients who did not use a cooling cap, none had hair after four rounds of chemotherapy.

The results were so striking that the trial’s data safety and monitoring board decided to halt the study early and release the results, according to a presentation Friday at the San Antonio Breast Cancer Symposium.

Chemotherapy works by killing rapidly dividing cells. That’s a hallmark of cancer cells, but they’re not the only ones that fit this description — unfortunately, hair cells divide rapidly too. That’s why chemotherapy treatments cause patients’ hair to fall out.


The idea behind the cooling caps is to reduce the assault on hair by delivering less of the chemotherapy agent to follicles on the head. By chilling the scalp to about 66 degrees Fahrenheit, the caps constrict blood vessels and reduce blood flow by 20% to 40%. Chemotherapy drugs travel through the bloodstream, so less blood flow to the scalp means less of the drug reaches vulnerable follicles.

In the trial, women with Stage 1 or 2 breast cancer donned the silicone caps 30 minutes before beginning their chemotherapy treatments. They kept the caps on throughout the treatment and for 90 minutes after it was over.

After four rounds of chemotherapy, hair loss was judged by independent evaluators who didn’t know whether a patient had used a cooling cap. Patients were considered to have “hair preservation” if their hair looked normal from a distance and they did not need a wig or other hair piece to mask their hair loss.

The study authors plan to follow the patients for five years to see if the reduction in chemotherapy paves the way for their cancer to spread to their scalp. They will also track their overall survival.

The cooling caps should work the same for patients with any kind of solid tumor, but the researchers tested it on breast cancer patients because hair loss presents a bigger emotional blow to women than to men, study leader Dr. Julie Rani Nangia of Baylor College of Medicine in Houston said in a statement. (The caps should not be used on patients with leukemia or other blood cancers because they constrict the blood vessels.)

The clinical trial tested the Orbis Paxman Hair Loss Prevention System, which is currently under FDA review by the FDA. If approved for use in the U.S., it would become an alternative to the DigniCap Scalp Cooling System, which received FDA approval last December.

Paxman Cooling, the company that makes the Orbis system, funded the trial presented in San Antonio.


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